Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Reported: June 22, 2022 Initiated: May 16, 2022 #Z-1270-2022
Product Description
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Reason for Recall
Due to a potential failed sterilization process.
Details
- Recalling Firm
- Volcano Corp
- Units Affected
- 11 devices
- Distribution
- U.S.: WA and WI O.U.S.: Canada
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891. Recalled by Volcano Corp. Units affected: 11 devices.
Why was this product recalled? ▼
Due to a potential failed sterilization process.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 22, 2022. Severity: Moderate. Recall number: Z-1270-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11